Friday, December 31, 2010

In a Fair Warningarticle about the dangers of the smoking cessation drug Chantix, the Food and Drug Administration was quoted as stating that it cannot ensure the safety of drugs after they are approved - that once drugs are put into widespread use, there is no telling what harms might occur.

According to the article: "Tragedy has plagued Chantix ever since it was approved in May, 2006, even as the drug has helped some smokers kick the habit. By mid-2009, the U.S. Food and Drug Administration had received reports of nearly 100 suicides, 200 attempted suicides and close to 5,000 serious psychiatric events overall. Hundreds of reports of side effects have continued to stream in this year. A review of the drug’s history shows that Pfizer Inc., the giant pharmaceutical company that makes Chantix, failed in its years of clinical trials to test the product on the mentally ill or those with a recent history of depression — even though millions of smokers suffer from psychiatric problems. Moreover, FDA regulators approved Chantix after a speeded-up “priority review” process, and did not request a follow-up study on mentally ill patients using the medication, even though the agency’s own safety reviewer reported that the exclusion of such smokers may have undermined the clinical trials. It wasn’t until three years later, after thousands of reports of serious side effects, that the FDA told Pfizer to conduct trials including people with a history of mental illness." ...

"Pfizer, for its part, defends Chantix and says it “acted responsibly and appropriately at all times in connection with the development, approval, and marketing” of the drug. The FDA, likewise, says it acted properly in approving the drug, despite the problems that emerged after it went on the market."

"“The agency does not feel any mistakes were made,” said FDA spokeswoman Sandy Walsh. “We can never speculate as to what may happen with a drug once it goes into widespread use after approval.”"

The Rest of the Story

It is quite comforting to know that the FDA can never speculate as to what might happen once a drug goes into widespread use after approval.

If the FDA is so unsure of its review process that it cannot even speculate as to the safety of an approved drug, then it's not clear what the purpose of that review process is.

And if the Agency will not acknowledge that any mistakes were made, even though it approved a drug that has killed many people and caused serious adverse consequences for thousands, then why should we believe that Agency review confers any level of safety assurance?

Obviously mistakes were made in the review of Chantix. A product was allowed onto the market which is clearly not safe. This doesn't mean that the Agency is to blame. It simply means that the Agency made a mistake and that the product turned out not to be safe. Arguing that no mistake was made is tantamount to admitting that the Agency is not set up to be able to ensure the safety of the nation's drug supply.

What is particularly troubling to me about the Chantix story is that the very same Agency which allowed this smoking cessation drug - which has killed many users and caused severe health consequences for thousands - to be marketed is now threatening to take electronic cigarettes - which have not been reported to kill or cause severe adverse consequences for a single user - off the market.

Since we know that Chantix is unsafe and can result in suicidal ideation or completed suicide, yet we insist on keeping Chantix on the market, then what justification is there for removing electronic cigarettes from the market even though there are no serious adverse effects yet reported? It just doesn't make any sense.

Speaking of not making any sense, it is even more ridiculous that the FDA now approves the sale and marketing of cigarettes - which kill hundreds of thousands of Americans each year - but has moved to ban electronic cigarettes, a product designed to save the lives of those Americans by giving them an effective alternative to nicotine replacement products for smoking cessation. The FDA would rather people use tobacco cigarettes than electronic ones. By what logic does it make sense to ban the safer cigarettes and approve the real ones?

The rest of the story is that we can all sleep better at night knowing that the Food and Drug Administration acknowledges that it has no idea - it cannot even speculate - as to the safety of drugs once they are approved and put into widespread use by consumers.

This story exposes the absolute folly of putting the regulation of cigarettes into the hands of the FDA. It completely undermines the mission of the Agency, a mission which it is already having a difficult enough time carrying out.

A lawsuit filed earlier this month in a San Francisco state court seeks to force McDonalds to discontinue the inclusion of toys in its Happy Meals, arguing that the marketing of toys to promote these meals represents unlawful, deceptive marketing and undermines parental autonomy.

According to a Bloombergarticle: "McDonald’s Corp., the world’s biggest restaurant chain, baits, exploits and ultimately harms children by offering toys with its “Happy Meals,” a Washington-based consumer advocacy group claimed in a lawsuit. The Center for Science in the Public Interest, in a complaint that its litigation director Stephen Gardner said was filed today at a state courthouse in San Francisco, accuses the company of deceptive marketing and business practices. ...“I don’t think it’s right to entice children into wanting Happy Meals with the promise of a great toy,” plaintiff Monet Parham said today in a telephone interview. The case was filed by her on behalf of her 6-year-old daughter, Maya. ... Boxed Happy Meals sold by the Oak Brook, Illinois-based restaurant chain typically consist of hamburgers, cheeseburgers or fried chicken, plus French fries or apple slices, a beverage and a toy. “By advertising that Happy Meals include toys, McDonald’s has helped create and continues to exacerbate a super-sized health crisis in California,” the nonprofit group said in its complaint." ...

"The center seeks class-action, or group, status on behalf of all of the state’s children under 8 years of age who have seen marketing for the company’s packaged children’s meals since December 2006. It also seeks an order barring the company from continuing to promote meals featuring toys on television, billboards and in its restaurants. ... “McDonald’s is engaged in a highly sophisticated scheme to use the bait of toys to exploit children’s developmental immaturity and subvert parental authority,” the organization alleged in its complaint."

The Rest of the Story

This is a bit too much. While I agree that fast food companies are marketing products in a way that is contributing to the nation's obesity epidemic, it is not unlawful marketing unless it is fraudulently deceptive. We can't just sue every company that markets products that contribute to public health problems.

The plaintiff stated: "I don’t think it’s right to entice children into wanting Happy Meals with the promise of a great toy." It would certainly be fraudulent to entice children into wanting Happy Meals with the promise of a great toy if McDonalds didn't provide such a toy. Yes, that would be deceptive marketing. But so far as I know, when you buy a Happy Meal, you do indeed receive said toy. So there is no deceptive practice here. You get exactly what was advertised.

The lawsuit argues that "by advertising that Happy Meals include toys, McDonald’s has helped create and continues to exacerbate a super-sized health crisis in California." But if that is grounds for a lawsuit, then every company in the nation that markets unhealthy products could be sued. Smith & Wesson is marketing products that literally kill thousands of Americans each year and have contributed to rampant violence in many cities. Does that make it unlawful for them to sell and market guns? Soda is contributing to the obesity crisis as well. Should we sue Pepsi and Coke for marketing a product that contributes to a national health crisis?

The lawsuit also argues that the marketing of toys with Happy Meals subverts parental authority. Exactly how? Unless the child has his own money, access to a car, a fake license, and can drive by himself, it seems to me that the parent has complete control over where the child eats and what food he eats once at the restaurant. No child can force a parent to buy a Happy Meal for them against the parent's will (although I've seen some children come fairly close).

Unfortunately, I think a lawsuit like this has the potential to undermine the use of litigation where it is really justified - such as in holding tobacco companies accountable for what truly were deceptive marketing practices. The attempt to translate tobacco industry litigation over to the fast food industry is fraught with problems because the situations are very different. Marketing of tobacco to children is illegal because the legal age of sale for cigarettes is 18. But there is no law prohibiting the sale of hamburgers or fried chicken to children. It may be unhealthy, but it is certainly not illegal.

In several recent Engle progeny lawsuits, juries have found that smokers were responsible for their decisions to smoke. How can we possibly hold that if a person is responsible for the decision to smoke, when he began smoking as a child and the product is addictive, that same person is not responsible for the decision to take his child to McDonalds? Is there no role for personal responsibility?

As readers know, I am quite open to the idea that there is a limitation on personal responsibility in the light of deceptive marketing practices that influence children, especially when a product is highly addictive and users who begin as minors may not be able to quit. But the marketing of toys with Happy Meals is simply not analogous to the marketing of cigarettes to minors.

I should also make it clear that I support the public health approach of framing issues such as obesity in terms of corporate responsibility. Interventions to educate the public about the role of fast food corporations in contributing to the obesity crisis are entirely appropriate. But this lawsuit is frivolous because it doesn't have any legal leg to stand on. And it could undermine legitimate attempts to hold companies responsible for damages that they are causing.

According to an article in the New York Times, the law was struck down because it violates the preemption clause in the Federal Cigarette Labeling and Advertising Act (FCLAA), which regulates the warnings that cigarette companies must place on cigarette packages and advertisements but preempts state and local regulation of same.

According to the article: "Judge Rakoff also cited a federal law enacted in 1965, the Labeling Act, which gave the federal government exclusive authority over cigarette warnings. That law, he wrote, seeks to balance public and commercial interests: the federal government protects the public, but also sets clear and uniform cigarette regulations that protect “commerce and the national economy.” In his ruling, Judge Rakoff pointed out that the Labeling Act also contained a provision forbidding any state laws from conflicting with the federal government’s policies on cigarette warnings and advertisements. That, he concluded, makes the city’s placard policy illegal."

According to the article, the New York City health department said it would appeal the ruling and issued the following statement: "The city’s warning signs portray completely factual messages about the dangers of smoking. They do so at the exact moment when smokers are making decisions about purchasing tobacco. We believe it is the city’s responsibility to help smokers quit and to protect children from the harmful effects of tobacco smoke."

The Rest of the Story

If it is the city's responsibility to promote healthy behavior by requiring stores to discourage consumers from buying their unhealthy products at point-of-sale, then shouldn't the city require all grocery stores to put graphic warning posters near the junk food aisle urging customers not to purchase these unhealthy snacks?

Shouldn't the city also require grocery stores to post graphic posters at the soda aisle urging customers not to purchase soda because of the morbidity and mortality caused by obesity, to which soda contributes significantly?

Shouldn't the city require tanning salons to post disgusting pictures of skin cancers at their entrances, urging potential customers not to enter?

Shouldn't wood stove stores be required to post graphic posters depicting the horrible consequences of lung disease, which we know is caused by wood smoke exposure?

New York City's graphic anti-smoking poster law was supported by twenty-five anti-smoking groups, including the American Medical Association, American Legacy Foundation, American Cancer Society, and American Lung Association, which intervened by filing an amicus brief in support of the law.

According to a press release announcing the submission of the amicus brief, Cheryl G. Healton, DrPH, president and CEO of Legacy, stated: "This filing reiterates how serious public health and policy leaders are about doing everything it takes to put an end to the hundreds of thousands of needless deaths from tobacco in this country every year. ... Simply put, public health must always trump tobacco sales."

If these groups are serious about doing everything it takes to put an end to the hundreds of thousands of needless deaths from tobacco in this country, and if they truly believe that public health must always trump tobacco sales, then why did most of these very same organizations support legislation that:

Ensures that nicotine will never be removed from tobacco products;

Exempts menthol from the ban on all other flavored cigarettes;

Restricts the ability of the FDA to increase the age of sale of tobacco products;

Precludes the FDA from regulating the places where cigarettes can be sold;

Makes it impossible for reduced risk products to be successfully developed and marketed; and

Puts the government in the position of officially approving cigarettes.

These organizations are a bunch of hypocrites. They state that they are doing everything possible to put an end to the hundreds of thousands of needless deaths from tobacco, yet at the same time, they worked to enact legislation which institutionalizes tobacco products, makes it impossible for safer tobacco products to enter the market, and ensures that youth access to tobacco cannot be effectively curtailed.

Now, these groups are once again promoting feel-good legislation that does very little to actually reduce tobacco use, but allows them to pretend that they are doing something meaningful.

These groups do not have the courage to stand up for actions that would actually be effective. They are unwilling to take a stand on principle, rather than on politics and political feasibility.

If tobacco products are so unsuitable for public consumption that New York City must require stores to actively discourage customers from buying their own products, then New York City needs to simply prohibit stores from selling that product. Clearly, it is not the public's health that is of paramount importance here - it is preserving cigarette sales in the city.

Thus, this law does the exact opposite of what its anti-smoking supporters say it does: it puts economic profits above public health.

If these groups support such extreme intervention on the part of New York City -requiring stores to actively discourage their customers from buying their products with graphic posters urging their customers not to buy their products - then why do they not support the step of simply telling these stores: "Sorry, but these products are so deadly that we cannot allow you to sell them."

The answer, obviously, is that these organizations are putting tobacco sales above the public's health. While these posters will do very little to discourage people from smoking, a ban on the sale of tobacco in they City would likely have a significant effect - especially in terms of reducing youth smoking. But no, instead of doing something that would actually make a difference, these groups are supporting a feel-good policy that makes absolutely no sense and caves in to political pressure and purely economic concerns.

Moreover, if these groups wanted local governments to be able to regulate the advertising and labeling of tobacco products, they should have insisted that the FDA tobacco legislation repeal the FCLAA's preemption of local cigarette labeling and advertising regulation, something which I pointed out in my critique of the proposed legislation.

The rest of the story is that these anti-smoking groups are hypocrites. They state that the public's health should always be placed above tobacco sales. Yet they supported legislation that compromised the public's health to protect tobacco sales. This is the definition of hypocrisy.

Wednesday, December 29, 2010

Two central Florida hospitals have a New Year's gift for smokers who successfully carry through on their New Year's resolutions to quit smoking and do so by using nicotine replacement therapy or electronic cigarettes: ineligibility for employment.

Starting January 1, not only will Florida Hospital Waterman in Tavares and Florida Hospital Fish Memorial in Orange City refuse to hire smokers, they will also refuse to hire ex-smokers who successfully quit using nicotine replacement products or electronic cigarettes and who are still using those smoking cessation products.

Thus, smokers who follow national guidelines and the advice of anti-smoking groups and use nicotine replacement products to quit smoking will not be eligible for employment, unless they discontinue the NRT and put themselves at risk of returning to smoking.

According to an article in the Orlando Sentinel, the director of employee health at the Cleveland Clinic described the rationale for these policies as follows: "The health-care organization should model health-care behavior. Therefore, health-care workers should not be smoking. When you're a provider of care, you have to be the best possible model you can be."

The Rest of the Story

If health care organizations should be modeling health care behavior, then why should they hire people who are overweight or obese? Shouldn't they also put prospective employees on a scale and throw out their applications if their body mass index is above healthy levels? After all, these organizations are supposed to be the best possible model they can be. Having overweight staff walking around is not exactly serving as the best possible model for the public.

In fact, the rationale for not hiring overweight people is much stronger than that for not hiring smokers. For the most part, the public is not going to know who the smokers are, because they are not smoking in the hospital. But it will be very clear to the public if an employee is overweight or obese. That will truly not serve as the best possible model for healthy behavior for the public.

Let's face it. Obesity is a severe public health problem whose costs rival those of smoking. The Centers for Disease Control and Prevention estimates that overweight and obesity are responsible for 9.1% of all medical costs in the nation. The CDC estimates that obesity costs the nation $147 billion per year.

Adding insult to injury, these Florida hospitals are actually penalizing the very behavior they purport to reward: smoking cessation. Smokers who successfully quit - and do so by using and maintaining themselves on NRT - are ineligible for employment. The only way for them to make themselves eligible is to discontinue the NRT, which would likely lead them to return to smoking. Thus, Orlando-area residents who make a New Year's resolution to quit smoking, use NRT as recommended, and succeed have are punished by these two hospitals, rather than rewarded. It seems to me that these hospitals should be welcoming ex-smokers, rather than turning them away (regardless of whether they quit using NRT or not).

The fact that these hospitals are making a statement against nicotine use, rather than against smoking, means that the policy is based on ideology or a sort of religion, rather than on health. This is an abstinence movement, not a health movement.

Tuesday, December 28, 2010

As the new year approaches, I am today announcing that the winner of the 2010 Tobacco Control Lie of the Year Award is ...

... the Office of the United States Surgeon General.

The Surgeon General's office takes the award for disseminating widely throughout the media the blatant lie that even brief exposure to secondhand smoke can cause cardiovascular disease and that inhaling even the smallest amount of tobacco smoke causes cancer.

Although all ten contestants, and the eight quarterfinalists, were all outstanding entries in that they all represented blatant lies, the clear sentiment of Rest of the Story readers was that the Surgeon General's office deserves the award because of the sheer magnitude of the impact of this lie. Given the influence of the Surgeon General's statements on anti-smoking groups and the prominence of the Surgeon General's statements in the media, the assertion that even a brief tobacco smoke exposure can cause heart disease and lung cancer is likely to be used successfully by anti-smoking groups to support an ever-increasingly aggressive agenda of banning smoking just about everywhere.

Second place goes to Free & Clear, for making the fraudulent claim that its smoking cessation program has a 45% six-month success rate, when its own research found only a 21% success rate using intention-to-treat analysis.

The rationale for the choice of Free & Clear as the runner-up for the 2010 Tobacco Control Lie of the Year Award is presented by John Polito, who wrote:

"Intentionally advertising a 17% quitting rate as 45% is a massive distortion that is helping Free & Clear make millions. While the other 9 misrepresentations are serious, none appear directly motivated by raw greed. The U.S. government's (Fiore's) bible on quitting rates is the 2008 Clinical Practice Guideline for Treating Tobacco Use and Dependence. The last paragraph on page 23 of the Guideline states: "All of the new meta-analyses conducted for the 2008 Guideline were based exclusively on intent-to-treat data." Guideline evidence Table 1.3 (above link at page 28) combines the results from 9 studies which examined pro-active telephone counseling. It found that six-month quitting rates ranging from 13.8% to 17.3%, producing a combined abstinence rate of 15.5%, with a rather modest 1.6 estimated odds ratio over minimal or no self-help (which would include unassisted cold turkey quitters). Now contrast that with this Free & Clear's page, which makes the following unqualified assertion: "Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.” Two giant fibs."

"Remember, we're talking about the nation's largest telephone quit smoking service, the 90 "trained," at-home Free & Clear counselors smokers talk to when calling 1-800-QUIT-NOW, probably the most expensive telephone quit counseling service on earth. The 1-800-QUIT-NOW number also appears on the U.S. government's official quitting site. Oklahoma is paying Free & Clear more than $900,000 per year, and "on average, the program has so far cost $700 to $835 for every person who has quit smoking."

"How many smokers understand how Free & Clear calculated its "responder rate" or what a responder rate even is. Any? Where does it tell us the percentage or number of smokers who actually "responded?" Another secret? What incentive does Free & Clear have to use diligence in following up with non-responders when it knows that the reason many don't want to talk to it is because they're still smoking? None. It's why Free & Clear deserves the award. By doing less and redefining quitting it makes itself look 3 times better than all other telephone counseling studies. It knows its representation is fraudulent yet with tens of millions at stake it feels the risks are worth the reward. Unless we somehow holds Free & Clear's feet to the fire, the health lies are profitable."

The Winners

FIRST PLACE: United States Surgeon General's Office

The Lie: (1) "Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack."; (2) "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The Rest of the Story: It is simply not true that even brief exposure to secondhand smoke can cause cardiovascular disease. Luckily, it takes many years of exposure before the process of atherosclerosis (hardening of the arteries) can occur. Fortunately as well, inhaling the smallest amount of tobacco smoke does not lead to cancer. While the Surgeon General is correct in asserting that the tiniest amount of tobacco smoke can damage your DNA, it simply is not true that someone who inhales the tiniest amount of tobacco smoke may well develop cancer because of it. There is certainly no evidence to support such a statement.

SECOND PLACE: Free & Clear

The Lie: "Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.”"

The Rest of the Story: What Free & Clear does not tell the consumer is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

Monday, December 27, 2010

Here are the 8 quarterfinalists for the 2010 Tobacco Control Lie of the Year Award:

1. Free & Clear

The Lie: "Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.”"

The Rest of the Story: What Free & Clear does not tell the consumer is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

2. United States Surgeon General's Office

The Lie: (1) "Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack."; (2) "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The Rest of the Story: It is simply not true that even brief exposure to secondhand smoke can cause cardiovascular disease. Luckily, it takes many years of exposure before the process of atherosclerosis (hardening of the arteries) can occur. Fortunately as well, inhaling the smallest amount of tobacco smoke does not lead to cancer. While the Surgeon General is correct in asserting that the tiniest amount of tobacco smoke can damage your DNA, it simply is not true that someone who inhales the tiniest amount of tobacco smoke may well develop cancer because of it. There is certainly no evidence to support such a statement.

3. Americans for Nonsmokers' Rights

The Lie: (1) "there are virtually no health disparities between active and passive smoking."; (2) "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."; (3) "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story: ANR's claim that there are virtually no health disparities between active and passive smoking is a lie. If ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe. How can ANR can claim that there are virtually no health disparities between active and passive smoking? That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers. If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false.

The statement that brief exposure to secondhand smoke causes heart damage in nonsmokers similar to that observed in active smokers is also a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack. Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage. ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is.

4. Florida Department of Health

The Lie: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

5. Maricopa County Department of Public Health

The Lie: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure. Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

The Rest of the Story: According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.

7. FDA and U.S. Department of Health and Human Services

The Lie: "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers."; "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The Rest of the Story: It is demonstrably false that flavored cigarettes are a gateway to cigarette smoking, that they contribute significantly to addiction of youths to tobacco, that the tobacco industry uses these flavored cigarettes to hook children, and that the FDA ban on candy-flavored cigarettes will have any impact whatsoever on youth smoking. (This is with the exception of menthol, the one flavoring which is actually used by the tobacco companies to hook kids, but which is exempt from the flavoring ban.) In fact, prior to the implementation of the law, not a single flavored cigarette brand (other than menthol cigarettes) produced by one of the major tobacco companies - including Philip Morris, Reynolds American, or Lorillard - was on the market. And the overall market share of flavored cigarettes among youth smokers was less than 0.1%. The truth is that nearly every youth who is addicted to tobacco smokes one of the major cigarette brands - including Marlboro, Camel, Newport, Kool, Winston, Parliament, and Basic. None of these are flavored cigarettes (again, with the exception of menthol, which I'll get to shortly). The truth is that the predominant gateway to youth smoking is non-flavored cigarettes (excluding menthol). The removal of flavored cigarettes from the market by the FDA will have no impact whatsoever on youth smoking. The only thing that would have had an impact is the removal of the non-flavored cigarettes - like Camels, Marlboros, and Newports - which are smoked by greater than 85% of all youth smokers.

8. American Cancer Society

The Lie: "The American Cancer Society, along with the broader public health community, fought the tobacco industry for more than a decade to get this historic legislation passed."

The Rest of the Story: The statement is simply not true. The biggest supporter of the FDA tobacco legislation, and a contributor of enormous lobbying expenditures in support of the bill, was none other than Philip Morris, the nation's largest tobacco company. Why does the American Cancer Society have to continue to lie like this? Why are they seemingly incapable of telling the American people the truth: that Philip Morris supported this bill?

Friday, December 24, 2010

Today I am announcing the finalists for the 2010 Lie of the Year Award, which will be given to the anti-smoking group which disseminated the most egregious lie during 2010. Unfortunately, there are a lot of very strong contenders for this year's award.

The quarter-finalists, semi-finalists, finalists, and winner will be announced over the course of next week, with the final winner announced just before New Year's Day. Feel free to vote for your top choices. Reader opinions will be taken into account in determining the winners.

I wish a Merry Christmas and happy holidays to all of my readers!

The Finalists

1. Free & Clear

The Lie: "Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.”"

The Rest of the Story: What Free & Clear does not tell the consumer is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

2. United States Surgeon General's Office

The Lie: (1) "Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack."; (2) "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The Rest of the Story: It is simply not true that even brief exposure to secondhand smoke can cause cardiovascular disease. Luckily, it takes many years of exposure before the process of atherosclerosis (hardening of the arteries) can occur. Fortunately as well, inhaling the smallest amount of tobacco smoke does not lead to cancer. While the Surgeon General is correct in asserting that the tiniest amount of tobacco smoke can damage your DNA, it simply is not true that someone who inhales the tiniest amount of tobacco smoke may well develop cancer because of it. There is certainly no evidence to support such a statement.

3. Americans for Nonsmokers' Rights

The Lie: (1) "there are virtually no health disparities between active and passive smoking."; (2) "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."; (3) "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story: ANR's claim that there are virtually no health disparities between active and passive smoking is a lie. If ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe. How can ANR can claim that there are virtually no health disparities between active and passive smoking? That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers. If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false.

The statement that brief exposure to secondhand smoke causes heart damage in nonsmokers similar to that observed in active smokers is also a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack. Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage. ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is.

4. Kentucky Center for Smoke-Free Policy, University of Kentucky College of Nursing

The Lie: "Even brief exposure to secondhand smoke can trigger a heart attack. ... In 20-30 minutes, fat and blood clots build up in the arteries, increasing the chance of heart attacks and stroke. After 2 hours of secondhand smoke exposure, the heart rate speeds up and leads to abnormal heart rhythms (which can lead to death)."

The Rest of the Story: Both of these statements are outright lies. You don't get a build up of fat and blood clots in the arteries in just 30 minutes. What happens in 30 minutes is that the cells lining your coronary blood vessels do not function normally, leading to a reduction in coronary flow velocity reserve. This damage to the blood vessel lining is reversible. However, if repeated over and over again and sustained for many years, these effects could contribute to the formation of atherosclerosis (hardening of the arteries). But it is a lie to state that 30 minutes of tobacco smoke exposure results in a build up of fat and blood clots in the arteries that increases the chance of a heart attack or stroke.

It is also untrue that 2 hours of exposure to secondhand smoke causes potentially catastrophic cardiac arrhythmias. What short-term tobacco smoke exposure can do is reduce heart rate variability. This is an important finding in that it provides biologic plausibility for the finding of a relationship between chronic secondhand smoke exposure and heart disease, but it does not mean that an individual exposed to tobacco smoke for 2 hours is at increased risk of dying of a cardiac arrhythmia.

5. Florida Department of Health

The Lie: "Non-smokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

6. Maricopa County Department of Public Health

The Lie: "Nonsmokers exposed to secondhand smoke for just 30 minutes experience hardening of the arteries."

The Rest of the Story: Just as with the lie from the Florida Department of Health, the study used to support this claim is also the Otsuka study. However, once again, that study did not show that nonsmokers exposed to secondhand smoke for just 30 minutes experienced hardening of the arteries. It merely showed that they sustained vascular injury in terms of endothelial damage. The subjects in the Otsuka experiment certainly did not experience hardening of the arteries. The Institutional Review Board would never have approved such a study if there was even a possibility that the subjects would develop atherosclerotic heart disease as a result of the 30 minute tobacco smoke exposure. Obviously, this claim is a lie. It is impossible for a person to develop hardening of the arteries in just 30 minutes. Even an active smoker needs to smoke for many years before developing hardening of the arteries. You don't have 17 year old smokers walking around with hardening of the arteries.

The Rest of the Story: According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.

8. FDA Center for Tobacco Products

The Lie: "research has found that children are especially attracted to and begin using tobacco products very early because of all kinds of pressures and motivations, including access to cigarettes that have candy-like characterizing flavors, such as mint, chocolate, cinnamon, coconut, and strawberry."

The Rest of the Story: If mint, chocolate, cinnamon, coconut, and strawberry cigarettes are a major reason for youth smoking, I challenge the Center for Tobacco Products to name a single brand of mint, chocolate, cinnamon, coconut, or strawberry cigarettes that was smoked by a significant number of youth during the past four years. The only existing brands of cigarettes in those flavors that I am aware of were marketed by R.J. Reynolds for a brief period from 2004 to 2006, but were voluntarily removed from the market in 2006. Thus, mint, chocolate, cinnamon, coconut, and strawberry cigarettes play no role in youth smoking initiation and the Family Smoking Prevention and Tobacco Control Act's prohibition of these flavors has removed none of these flavored cigarette brands from the market and has had no effect whatsoever on youth cigarette smoking.

9. FDA and U.S. Department of Health and Human Services

The Lie: "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers."; "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily."

The Rest of the Story: It is demonstrably false that flavored cigarettes are a gateway to cigarette smoking, that they contribute significantly to addiction of youths to tobacco, that the tobacco industry uses these flavored cigarettes to hook children, and that the FDA ban on candy-flavored cigarettes will have any impact whatsoever on youth smoking. (This is with the exception of menthol, the one flavoring which is actually used by the tobacco companies to hook kids, but which is exempt from the flavoring ban.) In fact, prior to the implementation of the law, not a single flavored cigarette brand (other than menthol cigarettes) produced by one of the major tobacco companies - including Philip Morris, Reynolds American, or Lorillard - was on the market. And the overall market share of flavored cigarettes among youth smokers was less than 0.1%. The truth is that nearly every youth who is addicted to tobacco smokes one of the major cigarette brands - including Marlboro, Camel, Newport, Kool, Winston, Parliament, and Basic. None of these are flavored cigarettes (again, with the exception of menthol, which I'll get to shortly). The truth is that the predominant gateway to youth smoking is non-flavored cigarettes (excluding menthol). The removal of flavored cigarettes from the market by the FDA will have no impact whatsoever on youth smoking. The only thing that would have had an impact is the removal of the non-flavored cigarettes - like Camels, Marlboros, and Newports - which are smoked by greater than 85% of all youth smokers.

10. American Cancer Society

The Lie: "The American Cancer Society, along with the broader public health community, fought the tobacco industry for more than a decade to get this historic legislation passed."

The Rest of the Story: The statement is simply not true. The biggest supporter of the FDA tobacco legislation, and a contributor of enormous lobbying expenditures in support of the bill, was none other than Philip Morris, the nation's largest tobacco company. Why does the American Cancer Society have to continue to lie like this? Why are they seemingly incapable of telling the American people the truth: that Philip Morris supported this bill?

Thursday, December 23, 2010

While the FDA has expressed concern about what it considers to be inaccurate marketing claims by electronic cigarette manufacturers that use of these devices will help customers to quit smoking, it is apparently overlooking a clear example of marketing fraud being perpetuated not by e-cigarette companies but by a company that is promoting a phone- and web-based smoking cessation program.

The American Cancer Society and Free & Clear's Quit for Life program is boasting to potential customers that it "produces an average quit rate of 45% for employers, making it 9 times more effective than quitting 'cold turkey.'"

According to the web site for Free & Clear: "The Quit For Life® Program is brought to you via a collaboration between the American Cancer Society® and Free & Clear®. As the nation’s leading tobacco cessation program, it employs an evidence-based combination of physical, psychological and behavioral strategies to enable participants to take responsibility for and overcome their addiction to tobacco use. Using an integrated mix of medication support, phone-based cognitive behavioral coaching and web-based learning and support tools the Quit For Life Program produces an average quit rate of 45% for employers, making it 9 times more effective than quitting “cold turkey.” We are so confident in our industry-leading performance that we are willing to put our fees at risk for agreed-upon service levels and outcomes that clients can easily track using our transparent reporting suite."

The Rest of the Story

What Free & Clear does not tell the consumer on its web site is that the quit rates reported on the site are known not to be accurate, as they are based only on survey responders and ignore respondents who are lost to follow-up, who we know are most likely those who have failed to quit smoking.

Free & Clear's own research has demonstrated that the actual quitting rates are likely to be much lower than the rates they are reporting. Thus, one could argue that Free & Clear is knowingly reporting a quit rate that is substantially higher than the actual quit rate. This, in my mind, is fraudulent marketing.

Let me try to explain the difference between a quit rate based only on survey responders and a quit rate based on all participants in the smoking cessation program (what is called an "intention to treat" quit rate).

Suppose I have a smoking cessation intervention. For the purposes of demonstration, let us say that my intervention consists of consuming a Vienna Finger every time a smoker trying to quit has a desire for a cigarette. I assemble a group of 100 people who want to quit and enter them into my Vienna Finger-assisted smoking cessation program.

After 6 months, I want to assess the percentage of participants who have successfully quit smoking. So I send out a survey to the 100 participants asking them if they are smoking at the present time.

Let's say I receive 20 surveys back, and 10 of those 20 respondents indicate that they have quit smoking.

I then have two basic choices for reporting the quit rate for my intervention:

First, I could base the quit rate only on those who have responded to the survey. There were 20 respondents and 10 indicated that they quit, so I could boast that the quit rate for my intervention is 50%. This is called a responder analysis or a responder quit rate.

Second, I could base the quit rate on all those who participated in the program. There were 100 participants, but I can only confirm that 10 of them quit smoking. Eighty respondents were lost to follow-up in the sense that they did not complete the evaluation survey. Chances are that a high proportion of the non-responders failed to quit smoking. One way to handle this is to assume that every non-responder failed to quit smoking. This is called an "intention-to-treat" analysis. The intention-to-treat quit rate would be 10 confirmed quitters out of 100 participants, or 10%.

You can see that with a low response rate, there is a vast difference between the responder quit rate and the intention-to-treat quit rate. What you need to recognize is that the true quit rate is somewhere in between the two quit rates. But most likely, it is much closer to the intention-to-treat quit rate. Why? Because research has demonstrated that non-responders are much, much more likely to be continuing or relapsing smokers.

The responder quit rate assumes that the rate of quitting among non-responders is the same as that among responders. This is an untenable assumption because non-response is almost certainly differential with respect to smoking status. In other words, those who are successful quitting are probably more excited about filling out the survey to tell you how successful the program was. Those for whom the program failed are much less likely to be excited and motivated to take the time to complete the survey.

Any company which only provides its responder quit rate is misrepresenting the true quit rate, unless the response rate to the survey was extremely high. In the case of Free & Clear, it appears that the survey response rate was not high enough to allow the company to use the responder quit rate as a valid indication of the effectiveness of the program.

An evaluation of the Free & Clear Quit for Life program, published in 2008 in the Journal of Medical Internet Research, found that 30-day quit rates at 6-month follow-up were 41% using responder analysis, but only 21% using intent-to-treat analysis.

Thus, the true quit rate is likely between 21% and 41%, but is probably much closer to 21%.

Free & Clear acknowledges that the 45% quit rate it boasts on its web site is based on the "responder quit rate." But it does not provide the intention-to-treat quit rate on that web page, nor does it inform the reader of the response rate to the evaluation survey.

In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

I find it interesting that the FDA is going to great lengths to take electronic cigarette companies to task for suggesting that these devices can help smokers quit (when there is abundant evidence that numerous vapers have found the product to be effective for smoking cessation), yet the FDA is silent in the face of this fraudulent marketing for medication- and counseling-based smoking cessation.

Data released by the Scottish National Health Service show that hospital admissions for acute myocardial infarction (heart attacks) in all of Scotland have failed to decline significantly after three years of the smoking ban being in effect.

The Scottish National Health Service has published monthly data on heart attack admissions in all Scottish hospitals for the one-year period prior to the smoking ban and the three year period following the ban. The smoking ban went into effect in April 2006. The graph below shows the number of hospital admissions for heart attack in Scotland during the following comparable periods:

April 2005 - March 2006: Pre-banApril 2006 - March 2007: First year post-banApril 2007 - March 2008: Second year post-banApril 2008 - March 2009: Third year post-ban

Here are the data visually:

Figure 1. Heart Attack Admissions for All of Scotland By Equivalent 12-Month Periods Before and After the National Smoking Ban

It is readily apparent from these data that although there was a small decline in heart attack admissions following the smoking ban, that decline was not sustained and heart attacks have now risen back up to the baseline level. Thus, the declines were apparently not due to the smoking ban and probably reflect random variation or secular changes in heart attacks that have nothing to do with the smoking ban.

Overall, from the year prior to the smoking ban to the 3rd year after the ban, there was a slight 2.3% decline in heart attack admissions.

The Rest of the Story

These data demonstrate that the conclusions made by Pell et al. in their study of the smoking ban's effect on heart attacks in Scotland were premature. While that study only looked at the first year after implementation of the smoking ban and only collected data for a sample of hospitals, the present data cover a full three years after the smoking ban and include admissions from all hospitals in Scotland.

Coming on the heels of the revelation that heart attacks actually increased in Isle of Man following its smoking ban and that the largest study to date more than 2 million heart attack occurrences throughout the United States found no significant relationship between smoking bans and short-term changes in heart attack admissions, these data add further support to my assertion that there simply is not evidence to conclude that smoking bans cause an immediate reduction in heart attacks, as is being claimed by many anti-smoking groups.

This shows the dangers of disseminating conclusions to the public that are not based on rigorous scientific methods. If you end up being wrong, you are going to look bad and your scientific reputation is going to be shot. Better to be more careful in the first place and to be beyond reproach in your scientific integrity.

Special thanks to Christopher Snowdon over at Velvet Glove, Iron Fist, who first reported and analyzed these data. Snowdon provides more detailed data, including a month-by-month analysis, data for both heart attacks and acute coronary syndrome, and excellent graphs which nicely illustrate the true trends in heart attack admissions in Scotland.

Wednesday, December 22, 2010

A new unpublished study has reported finding a 36% increase in heart attacks in Isle of Man following the implementation of an island-wide ban on smoking in public places and workplaces which was implemented in March 2008.

The study compared the number of heart attack admissions in Isle of Man during the two-year period prior to the smoking ban with the number of heart attack admissions during the two-year period following the smoking ban.

Because Isle of Man is an island with only one hospital, it serves as an excellent location in which to study changes in heart attack admissions in association with a smoking ban.

The study findings are presented as follows: "Before the smoke free legislation was introduced, myocardial infarctions episodes (admissions) were increasing at a rate of 0.23 per month. This means that roughly every 4 months there would be, on average, one more patient admitted with myocardial infarction in the Isle of Man than the previous 4 months? In the 2 years after the legislation was put in place, the results show that there was no longer an average increase."

The study conclusion is as follows: "This study provides some evidence which, together with related studies carried out in different countries, demonstrates that laws enforcing smoke free regulations in public areas may be associated with a reduction in myocardial infarction admissions and so a concomitant reduction in the incidence of MI in the population."

A press release accompanying the study report asserted that: "The statistical analysis of the data shows that there was a significant reduction in the rate of admissions to Noble’s Hospital for heart attacks amongst males aged over 54." The press release concluded that: "We are pleased to be able to demonstrate a local positive health effect resulting from the tobacco legislation."

The press release was picked up by several news outlets. For example, a headline on the BBC News web site boasted: "Isle of Man smoking ban 'cuts heart attacks'."

The Rest of the Story

You are probably wondering - how could the study and press release conclude that the Isle of Man smoking ban cut heart attacks if the number of heart attack admissions increased by 36%?

The answer is simple: sleight of hand.

When the researchers found that heart attacks went up, not down, in Isle of Man after the smoking ban, they apparently used a trick to make it appear that the smoking ban decreased the number of heart attacks. What they did was to examine the difference in the rate of change in heart attacks from before to after the smoking ban.

This technique is fine when you have many years of data, so that you can accurately determine the rates of change in heart attacks. However, with just two years of data in the baseline period, it is not possible to accurately determine the rate of change in heart attacks.

The fact remains that the major finding of the study is that there was an increase, not a decrease in the number of heart attack admissions following the smoking ban. Here are the actual results:

During the period April 2006 through February 2008 (prior to the smoking ban), there were 216 heart attacks, or a rate of 9.4 heart attacks per month.

During the comparable period April 2008 through February 2010 (after the smoking ban), there were 293 heart attacks, or a rate of 12.7 heart attacks per month.

Thus, the heart attack rate increased from 9.4 heart attacks per month to 12.7 heart attacks per month, an increase of 36%.

If one compares the number of heart attacks during comparable months from before to after the smoking ban, it turns out that for 20 of the 23 months, heart attacks went up. For 2 of the 23 months, heart attacks went down. For 1 of the 23 months, heart attacks were the same.

To interpret these data as showing evidence of a significant decline in heart attacks associated with the smoking ban is beyond comprehension.

This study is truly an example of playing with statistics in order to try to support a pre-determined conclusion, rather than simply reporting objectively the findings of an analysis.

Unfortunately, the improperly interpreted and grossly distorted results of this study have been disseminated widely throughout the world via the media. Headlines such as: "Heart Attack Rates Fall Following Smoking Ban" are spreading rapidly. What the public is not being told, however, is that this study actually found a 36% increase in the number of heart attack admissions in the two years following the smoking ban.

To make it clear, I am not arguing here that the smoking ban caused an increase in heart attacks. The number of heart attacks is extremely small and there are many other factors related to changes in heart attack rates. However, what is clear from this study is that it absolutely does not provide evidence that the smoking ban resulted in a decrease in heart attack admissions in Isle of Man. Any group which is disseminating such a conclusion is spreading scientifically shoddy information.

For more on this story, don't miss Christopher Snowdon's post over at Velvet Glove, Iron Fist, where he dissects this study in a way very similar to my own analysis.

Monday, December 20, 2010

Most Definitive Study to Date Refutes Conclusions of Many Earlier Studies and Demonstrates Why These Studies Obtained Positive Findings

A new study by researchers from the RAND Corporation, Center for Studying Health System Change, University of Wisconsin, and Stanford University is the first to examine the relationship between smoking bans and heart attack admissions and mortality trends in the entire nation, using national data. All previous U.S. studies only examined one particular city. In contrast, this study examined data from the Nationwide Inpatient Survey (NIS), which is nationally representative and includes 20% of all non-federal hospital discharges in the United States. The study appears in the Winter 2011 issue of the Journal of Policy Analysis and Management.

1. "In contrast with smaller regional studies, we find that smoking bans are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction or other diseases."

2. "An analysis simulating smaller studies using subsamples reveals that large short-term increases in myocardial infarction incidence following a smoking ban are as common as the large decreases reported in the published literature."

The study uses state and local workplace smoking ordinance data from the American Nonsmokers' Rights Foundation tobacco control database for the years 1989 through 2004 and national data on heart attack admissions and mortality from the National Inpatient Survey (1993-2004), as well as from the Multiple Cause of Death database (1989-2004) and Medicare Provider Analysis and Review files (1997-2004). Using a fixed effects regression model, the authors analyze outcomes (heart attack admissions and mortality) before and after the implementation of all workplace, bar, or restaurant smoking bans in the nation, as identified in the ANR database.

The regression coefficient of interest represents the change in heart attack admissions or mortality associated with the implementation of a smoking ban, while controlling for secular trends in the outcome variable as well as regional differences in outcomes and regional differences in population size, number of physicians, number of hospital beds, household income, and percent of the population in the labor force.

The study also simulates the results from the comparison of all possible combinations of regions in the U.S. by examining subsets of the data, where one region is an intervention unit and the other is a comparison or control unit. The authors are therefore able to simulate what the results would be for each of the 15,824 possible comparisons of intervention and control regions in the country.

The main study result is that the regression coefficients for the smoking ban variable is not statistically significant in either the heart attack admission or heart attack mortality model, indicating that the smoking bans had no effect on either heart attack admissions or heart attack mortality.

The study estimates that workplace smoking laws increased heart attack mortality by a non-significant 1.9%, with a 95% confidence interval of -0.9% to +4.7%. The study estimates that workplace smoking laws reduced heart attack admissions among 18-64 year-old adults by a non-significant 3.6%, with a 95% confidence interval of -9.6% to +2.5%.

The study estimates that workplace smoking laws reduced heart attack hospitalizations by a non-significant 2.0%, with a 95% confidence interval of -7.0% to +3.0%. The study estimates that workplace smoking laws increased heart attack admissions among 18-64 year-old adults by a non-significant 1.8%, with a 95% confidence interval of -4.5% to +8.0%.

There was also no significant effect of any smoking restrictions (including bar and restaurant smoking bans) on either heart attack admissions or mortality.

Most interestingly, the simulation of all possible comparison studies of local regions in the U.S. finds that just as many studies would find an increase in heart attacks associated with smoking bans as would find a decrease in heart attacks (see Figure 2). The mean difference in heart attack admissions among all studies was 0. The exact same result was found for heart attack mortality (see Figure 3).

The paper concludes: "We find no evidence that legislated U.S. smoking bans were associated with shortterm reductions in hospital admissions for acute myocardial infarction or other diseases in the elderly, children, or working-age adults." ...

"We show that there is wide year-to-year variation in myocardial infarction death and admission rates even in large regions such as counties and hospital catchment areas. Comparisons of small samples (which represent subsamples of our data and are similar to the samples used in the previous published literature) might have led to atypical findings. It is also possible that comparisons showing increases in cardiovascular events after a smoking ban were not submitted for publication because the results were considered implausible. Hence, the true distribution from single regions would include both increases and decreases in events and a mean close to zero, while the published record would show only decreases in events. Publication bias could plausibly explain the fact that dramatic short-term public health improvements were seen in prior studies of smoking bans." ...

"We show that positive and negative changes in AMI incidence are equally likely after a smoking ban, which suggests that publication bias, not outcome heterogeneity, explains the skewed results seen in prior reviews. The IOM and other policymakers have relied on the weight of the published literature when making decisions. However, it appears that publication bias did not receive sufficient attention. Our results suggest that only positive studies have been published thus far, and the true short-run effects of governmental workplace smoking bans would be more modest in the U.S. inclusion of such unpublished negative studies might change the conclusions of the IOM and other decision makers on this issue."The Rest of the Story

Without a doubt, this is the most definitive study yet conducted of the short-term effects of smoking bans on cardiovascular disease.

To give you an idea of the scope of this study compared to previous ones, the Helena study involved a total of 304 heart attack admissions in one community over a period of six months. This study examined a total of 673,631 heart attack admissions and more than 2 million heart attack deaths in 467 counties across all 50 states over an 16-year period.

This study fails to find any significant short-term effect of smoking bans on heart attack admissions or heart attack mortality, although a small effect cannot be ruled out. The study refutes the claims from previous studies that smoking bans result in a short-term reduction in heart attacks in the range of 20-40%, as many anti-smoking groups are asserting. It also refutes the conclusion of the Institute of Medicine that smoking bans result in immediate, substantial declines in heart attack admissions.

The most important finding of this study is that there are just as many smoking ban communities in which heart attack admissions and mortality have increased in comparison with control communities as there are smoking ban communities in which heart attacks have decreased relative to control communities. The mean difference was found to be zero.

Thus, the study not only fails to find a short-term effect of smoking bans on heart attacks, but it also explains the positive findings of previous studies. What appears to be going on is what is referred to as publication bias.

What this means is the following: if one wanted an unbiased estimate of the effect of smoking bans on heart attacks, one would ideally include all communities that have enacted a smoking ban. In reality, what has occurred is that there have been what essentially amount to anecdotal studies conducted in several communities. These few studies have been published in the literature. It is possible that similar studies were conducted that failed to find an effect and that these studies were therefore not published. It is also possible that the finding of positive results in the few communities studied was essentially a result of chance. There may be other reasons why certain communities were selected for study. For example, researchers may subconsciously have a feeling that heart attacks have decreased and may want to conduct research to confirm if this is the case or not.

For whatever reason, it is apparent that the sample of communities in which this issue has been studied represents a biased sample of all possible studies that could have been conducted. When one examines, systematically, data for all regions in which smoking bans have been enacted, one fails to find a significant effect of smoking bans on either heart attack admissions or heart attack mortality.

This doesn't meant that smoking bans will not eventually result in reductions in cardiovascular disease. That will take considerable time. It just means that the conclusions of anti-smoking researchers and groups that heart attacks drop immediately upon passage of smoking bans appear to be wrong.

When I first questioned the validity of the conclusions of the Helena and Pueblo studies, I was attacked by many of my colleagues, called a traitor, and expelled from list-serves because they did not want me to spread my dissenting opinion. Now, it has become quite clear that my skepticism was well-placed to begin with. The most definitive study to date has refuted the findings of these studies.

It is important for me to point out that I never took issue with the data presented in the individual studies. There were demonstrable declines in heart attack admissions in the intervention cities. What I questioned was the conclusion that these declines were attributable to the smoking ban, rather than to random variation in the data and/or secular changes in heart attacks, which we know are declining throughout the country, even in the absence of smoking bans. There have been considerable advances in surgical and pharmaceutical treatments for coronary heart disease and these may well be the major contributing factors to the observed decline in heart attack rates.

This new research demonstrates why tobacco control researchers and groups have to be very careful in drawing causal conclusions, and why it is better to uphold high standards of scientific rigor rather than to jump to premature conclusions that may later be shown to be incorrect. Tobacco control groups, and the movement as a whole, will lose some scientific credibility because of these new findings which do not support their conclusions. But it is too late to retract those conclusions because they have already been widely disseminated through the media.

It is far better to get it correct the first time. But that requires adherence to solid science. You cannot allow advocacy concerns and goals - no matter how noble they may be - to interfere with the process of objective scientific evaluation. That is exactly what has occurred in tobacco control.

The rest of the story is the best available evidence does not support the conclusion that smoking bans have resulted in immediate, substantial declines in heart attack admissions, as anti-smoking groups as well as the Institute of Medicine boasted. The anti-smoking groups and IOM did not adequately take into account the role of publication bias. Neither did they adequately take into account the lack of control groups in most of the studies, as well as the failure of these studies to rigorously control for secular trends in heart attack admissions and to rule out alternative explanations for the study findings.

Of course, my readers will understand that the lack of a short-term effect of smoking bans on heart attacks does not mean that these are not important policies that protect the public's health. It simply means that anti-smoking groups have been wrong in touting this claim and that the scientific rigor in the anti-smoking movement has disintegrated.

Now here is the really interesting question:

Will anti-smoking groups share and/or publicize the results of this new study or will they simply ignore evidence that does not fit their pre-determined conclusions?

A new study released this week is taking a strong stand against the Food and Drug Administration’s entrenched skepticism of electronic cigarettes as a harm reduction alternative to tobacco cigarettes. The study is the first to comprehensively review the scientific evidence about the safety and effectiveness of electronic cigarettes. After reviewing 16 laboratory studies of the constituents of electronic cigarettes, the study authors argue that electronic cigarettes are much safer than the real ones and therefore show tremendous promise in the fight against tobacco-related morbidity and mortality. Nevertheless, the FDA is threatening to ban them from the market, an action that would benefit the tobacco companies at the expense of the public’s health, according to the study, which appears online ahead of print this month in the Journal of Public Health Policy. The study’s co-authors are Zachary Cahn, a graduate student in the Department of Political Science at UC Berkeley and Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Public Health.

According to Dr. Siegel, “The FDA and major anti-smoking groups keep saying that we don’t know anything about what is in electronic cigarettes. The truth is, we know a lot more about what is in electronic cigarettes than regular cigarettes. Our review shows that carcinogen levels in electronic cigarettes are up to 1,000 times lower than in tobacco cigarettes. No other constituents have been detected at levels that are of significant health concern. Thus, using electronic cigarettes (also called vaping) appears to be much safer than smoking. Taking these products off the market would force thousands of vapers to return to cigarette smoking. Why would the FDA and the anti-smoking groups want to take an action that is going to seriously harm the public’s health? The only ones who would be protected by a ban on e-cigarettes are the tobacco companies, as these new products represent the first real threat to their profits in decades.”

The FDA has seized electronic cigarette shipments from two companies and has threatened all electronic cigarette distributors with enforcement action against them if they continue to sell this product. Six national anti-smoking groups – the American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, American Legacy Foundation, and Action on Smoking and Health – have called for the removal of electronic cigarettes from the market.

Regarding the relative safety of electronic cigarettes, the study concludes that “few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.”

The study also reviews preliminary evidence that electronic cigarettes can be effective in suppressing the urge to smoke, largely because they simulate the act of smoking a real cigarette. “The fact that bothers the anti-smoking groups the most – that vaping looks like smoking – is precisely the fact which appears to make e-cigarettes an effective tool for smoking cessation,” notes Dr. Siegel.

Regarding the effectiveness of electronic cigarettes for smoking cessation, the study concludes as follows: “Although more research is needed before we will know how effective electronic cigarettes are at achieving smoking abstinence, there is now sufficient evidence to conclude that these products are at least capable of suppressing the urge to smoke.” There is also reason to believe that they offer an advantage over traditional nicotine delivery devices, the study argues, because smoking-related stimuli alone have been found capable of suppressing tobacco abstinence symptoms for long periods of time.

Siegel and Cahn conclude: “The evidence reviewed in this article suggests that electronic cigarettes are a much safer alternative to tobacco cigarettes. They are likely to improve upon the efficacy of traditional pharmacotherapy for smoking cessation.” While more research is needed, the article concludes that electronic cigarettes show promise as a harm reduction strategy and that removing them from the market would substantially harm the public’s health.

Wednesday, December 15, 2010

According to an article in The Age, the Australian Medical Association and the anti-smoking group Quit Victoria are saying that there is no evidence electronic cigarettes can help smokers quit, while before their very eyes, thousands of Australians are quitting smoking by switching to electronic cigarettes.

Although e-cigarettes were banned in Victoria last January, the products are in such demand that smokers continue to purchase them online, apparently a sign of their effectiveness in helping people get off cigarettes.

According to the article: "The Australian Medical Association and Quit Victoria say there is no evidence smokeless, battery-powered ''e-cigarettes'' packed with nicotine can help people quit, and they warn that such products have not been tested for safety and could pose a serious health risk."

At the same time: "Thousands of Australian smokers are switching to ... electronic cigarettes despite a ban on the products, which are being marketed as the ''healthy'' way to kick the habit."

The Rest of the Story

With the evidence right in front of their very eyes, anti-smoking and health groups in Australia are apparently so blinded by ideology that they cannot see the facts which are unraveling before them.

Apparently, electronic cigarettes are so helpful to smokers that they are in demand in spite of a ban on the product. And apparently, thousands of smokers are using the product in an attempt to quit smoking, many of them with success.

Ironically, the Quit Victoria web site, which publishes smokers' success stories (in quitting), displays the story of two smokers who were successful quitting with the use of electronic cigarettes. Apparently, they don't read their own web site.

It appears that like their counterparts in the U.S., anti-smoking groups in Australia are also blinded by ideology, which leads them to oppose anything that looks like smoking, regardless of what the evidence shows.

The existing evidence demonstrates that electronic cigarettes can be effective in suppressing the urge to smoke. This effect is probably due largely to the behavioral stimuli that vaping produces, which are quite similar to smoking. Anti-smoking groups have overplayed the pharmacologic aspect of smoking addiction, and largely ignored the behavioral and psychological aspects of the addiction. But there is a body of research evidence which reveals that nicotine alone is not enough to suppress the urge to smoke, and that behavioral stimuli alone (sham smoking) can suppress cigarette cravings, even in the absence of nicotine. The advantage of electronic cigarettes is that they deliver both: they address both the pharmacologic and the behavioral/psychological aspects of the smoking addiction.

The existing evidence also demonstrates that vaping is likely far less hazardous than smoking. Moreover, no constituents of the electronic cigarette vapor have been implicated in disease causation at the levels that have been detected in laboratory studies. In fact, tobacco-specific nitrosamines are present in only trace levels in e-cigarettes, compared to very high levels in regular cigarettes. How anti-smoking groups can be aware of such evidence yet continue to claim that there is no indication that e-cigs are any safer than regular ones is beyond me.

The rest of the story is that anti-smoking groups have become blinded by their adherence to ideology and are no longer seeing the scientific evidence that is before their eyes. Unfortunately, smokers would be better served by taking the matter into their own hands, doing their own research, and making their own decision about what course of action is most likely to improve their health. Fortunately, thousands of Australians appear to be doing just that.

Tuesday, December 14, 2010

Although the Surgeon General's claim that a single cigarette can kill you has been gaining the most attention, there is another major conclusion of the Surgeon General's report that is far more meaningful. The report reviews evidence regarding the basic approach to reducing tobacco-related disease that was taken in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act): lowering levels of specific toxic constituents in tobacco smoke.

A major conclusion of the report is that there is no evidence that reducing levels of specific tobacco smoke constituents will lead to a decrease in human disease.

The report concludes that: "the evidence today does not demonstrate that efforts to lower machine-measured tar and nicotine yields actually decreased the health risks of smoking." Furthermore, "no relationship exist[s] between machine-measured tar and nicotine levels and risks for most categories of cigarette-related diseases."

The report emphasizes that "changes to reduce machine-measured tar and nicotine yields in cigarettes did not have a measurable beneficial impact on public health."

The report notes that even when cigarette companies reduced nitrosamine levels by 70%, there was no evidence of any reduction in health risk of these new products: "For example, Brown & Williamson introduced Advance as a new cigarette with the claim that levels of tobacco-specific nitrosamines (TSNAs) were 70 percent lower than those in leading “light” brands (Star Scientific 2005). Preliminary laboratory studies of cigarette smokers provide mixed evidence for the possibility that use of this cigarette substitute would result in reduced exposure to tobacco toxicants (Breland et al. 2002, 2003). Omni, manufactured by Vector Tobacco, is a conventional cigarette for which the marketers claimed lower levels of carcinogenic polycyclic aromatic hydrocarbons, nitrosamines, and catechols (Vector Group 2001). Preliminary studies in which Omni is smoked instead of the smokers’ usual brand of cigarettes provide little evidence for reduced exposure to toxicants (Hatsukami et al. 2004b; Hughes et al. 2004)."

One reason for the absence of any relationship between levels of toxicants and product risk, according to the report, is that "the extent to which exposure to toxicants is actually reduced in smokers is not known because reduced machine-measured yields of toxicants do not necessarily reflect actual human exposure."

In fact, the report emphasizes that reductions in specific constituents in tobacco smoke may actually increase, rather than decrease, the risks associated with cigarette smoking: "products delivering lower levels of nitrosamines might theoretically reduce cancer risks, but because many of these products still deliver nicotine and CO, cardiovascular risks may remain unchanged or may even increase. In addition, if TSNAs are removed, other potent carcinogens may sustain overall high levels of exposure to carcinogens."

Furthermore, disease risk associated with lower-emission cigarettes may increase, or remain unchanged, for the following reason: "A smoker who switches to a brand with lower machine-measured toxicants may smoke these cigarettes in a more intense fashion or may consume more cigarettes per day than previously. Either change could result in greater human exposure to toxicants and no decrease in risk of disease."

Finally, the report notes that: "There are substantial risks that the marketing of novel cigarettes could lead to increased tobacco use in current smokers, relapse in former smokers, and initiation in those who never smoked, particularly youth."

The Rest of the Story

The Surgeon General's report destroys the entire scientific basis for FDA regulation of cigarettes: the contention that by lowering levels of various constituents in tobacco smoke, the FDA can mandate changes which will decrease the risk of disease and thereby improve the public's health.

On the contrary, the Surgeon General's report concludes that there is no scientific basis for the contention that lowering specific toxicants in cigarette smoke will reduce human disease. In fact, according to the report, such changes could actually increase overall disease in the population.

Not only does this blow the FDA Tobacco Act out of the water, but it also blows out of the water the FCTC's proposed regulation of cigarette toxicant levels.

Furthermore, the Surgeon General's report reveals that the anti-smoking groups lied to the American public when they claimed that regulating specific toxicant levels in cigarettes would save countless lives. There was no scientific evidence to support such a statement. Moreover, it is possible that such an approach could actually increase tobacco-related deaths.

I find it interesting that when a tobacco company introduces the idea of reducing levels of certain carcinogens or toxicants in their products, the anti-smoking groups attack the companies and tell the public that these companies are lying, acting fraudulently, and conspiring to defraud the American people. But when the anti-smoking groups claim exactly the same thing, the lie suddenly becomes truthful. What kind of magic do the anti-smoking groups possess that they can repeat the precise lies that the tobacco companies told, but have them instantaneously turn into the truth?

The answer, of course, is that there is no magic here. Tobacco-related disease risk is dictated by science, not magic. And so the rest of the story is that the anti-smoking groups are lying to you. When they argue that regulating specific constituents in tobacco products is going to save countless lives, they are lying to you.

The World Health Organization, or at least its tobacco regulation group, is also lying to you.

You see, the truth is that the FDA regulation of tobacco products is a huge scam. You simply can't regulate the safety of a product that is killing more than 400,000 Americans each year. It is an absurd notion to begin with. The entire idea is a scam set up to make it look like our politicians really care about reducing tobacco-related disease, but without having to actually take the courageous moves necessary to pass legislation that Philip Morris opposes and which therefore truly has the potential to save lives by substantially reducing tobacco use.

The scam was also set up to bring fame and glory to anti-smoking groups, allowing them to solicit contributions by boasting about how they brought Big Tobacco to its knees. All this without telling their constituents that the largest company in Big Tobacco actually supported the legislation and was not on its knees, but standing tall and strong and buttering up its bank accounts.

In fact, on the day that the anti-smoking groups congratulated themselves for removing so-called flavored cigarettes from the market, Philip Morris introduced a brand new flavored cigarette, exposing the anti-smoking groups for the frauds that they are.

The Surgeon General's report reveals that the fraud goes even deeper than you might have thought. The entire premise for the FDA regulation of tobacco products - the idea that by lowering levels of certain constituents, lives can be saved - has now been demonstrated to be a fraudulent claim.

It is no less fraudulent simply because it is now anti-smoking groups which are making the claim instead of tobacco companies. Remember, the fraud is not a result of who is making the statement. It is a result of the lack of truth in the statement itself. And the statements that the anti-smoking groups have made - what they have led you to believe about how the FDA regulation of specific constituents in cigarettes is going to make the product safer and save lives - is untruthful. In fact, with all due respect to the tobacco companies, this may be the greatest fraud in tobacco control history.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.